Products
Products
Designed for medical device manufacturers, SaMD developers, and digital health teams who want an honest, expert assessment of where their quality management infrastructure stands — and what it will take to get to audit-ready, submission-ready, or investor-ready.
This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No slides, no sales pitch. Just a focused, candid discussion about your product, your team, and the most direct path to a defensible QMS.
What We Cover
Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage — which may include the current state of your quality documentation, your ISO 13485 framework and any known gaps, software lifecycle controls if your product involves SaMD, risk management alignment, design control structure, traceability, and your readiness for FDA review, notified body audit, or internal compliance milestones.
What You Walk Away With
A clear picture of where your QMS stands today, a prioritized sense of the gaps that matter most, and a straightforward recommendation on whether a productized documentation system, a custom consulting engagement, or a combination of both is the right next step for your organization.
Who This Is For
This consultation is built for teams at any stage — whether you are building a QMS from scratch, reinforcing an existing system ahead of an audit, closing documentation gaps before a submission, or establishing quality infrastructure ahead of a funding round or strategic partnership. If you are unsure where to start or what you actually need, this call will give you clarity.
How It Works
We will contact you for a time that works for you. You will receive a brief preparation guide to help focus the conversation on your specific product, lifecycle stage, and regulatory context. No formal preparation required beyond that.
What This Is Not
This consultation is not a substitute for a full regulatory strategy engagement, submission support, or ongoing quality management consulting. If your needs extend beyond documentation and readiness assessment, contact us for something that may be a better fit.
Designed for SaMD developers, digital health teams, and medical device manufacturers who want a clear-eyed assessment of where they stand against current FDA cybersecurity expectations — before it becomes an audit finding or a submission delay.
This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No slides, no sales pitch. Just an honest, expert review of your current cybersecurity posture relative to FDA premarket and post-market guidance requirements.
What We Cover
Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage — which may include your threat modeling and risk control documentation, SBOM status, secure development lifecycle practices, traceability between threats and verification evidence, and your overall readiness for a premarket submission or regulatory inspection.
What You Walk Away With
A clear picture of your most significant cybersecurity documentation gaps, a prioritized sense of where to focus remediation effort, and a straightforward recommendation on whether a productized solution, a custom consulting engagement, or a combination of both is the right next step for your organization.
Who This Is For
This consultation is built for teams preparing for an FDA premarket submission, responding to an audit finding, or simply trying to understand where their cybersecurity documentation stands against current regulatory expectations. It's equally valuable for first-time submitters and experienced teams navigating the post-2023 FDA cybersecurity guidance landscape.
How It Works
We will contact you for a time that works for you. You'll receive a brief pre-call questionnaire to help focus the conversation on your specific product, lifecycle stage, and regulatory context. No preparation required beyond that.
What This Is Not
This consultation is not a substitute for a full cybersecurity strategy engagement, submission support, or ongoing quality management consulting. If your needs extend beyond documentation and readiness assessment, contact us for something that may be a better fit.
Designed for medical device manufacturers and development teams who need an expert eye on their Design History File — whether you are preparing for an FDA inspection, responding to a 510(k) deficiency, or simply unsure whether your DHF would hold up under scrutiny.
This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No slides, no sales pitch. Just a focused, candid assessment of where your DHF stands and what it will take to get it inspection-ready.
What We Cover
Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage — which may include your DHF structure and completeness, design input and output documentation, design review records, verification and validation coverage, traceability between requirements and test evidence, design transfer documentation, and alignment with 21 CFR Part 820 and ISO 13485 design control requirements.
What You Walk Away With
A clear picture of your most significant DHF gaps, a prioritized remediation roadmap, and a straightforward recommendation on whether a productized documentation system, a targeted consulting engagement, or a combination of both is the right next step for your organization.
Who This Is For
This consultation is built for device manufacturers at any stage — whether you are building your DHF for the first time, remediating gaps identified in an FDA warning letter or inspection observation, closing deficiencies flagged in a 510(k) review, or simply stress-testing your existing DHF before your next audit. If your DHF keeps you up at night, this call is for you.
How It Works
We will contact you for a time that works for you. You will receive a brief preparation guide to help focus the conversation on your specific device, development stage, and regulatory context. No formal preparation required beyond that.
What This Is Not
This consultation is not a substitute for a full DHF audit, regulatory strategy engagement, submission support, or ongoing quality management consulting. If your needs extend beyond an advisory conversation, [link to your consulting services page] may be a better fit.
Designed for medical device manufacturers and SaMD development teams who need clarity on their V&V strategy — whether you are building a validation framework for the first time, closing gaps ahead of a submission, or untangling a V&V approach that has grown inconsistent over time.
This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No slides, no sales pitch. Just a focused, expert discussion about your product, your current V&V posture, and the most defensible path forward.
What We Cover
Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage — which may include your overall V&V master plan structure, unit and integration testing coverage, system and user acceptance testing, requirements traceability between design inputs and test evidence, risk-based validation approaches, software validation considerations under IEC 62304, and alignment with FDA expectations for verification and validation documentation.
What You Walk Away With
A clear assessment of where your V&V strategy stands today, identification of the gaps most likely to draw FDA or notified body scrutiny, and a straightforward recommendation on whether a productized documentation system, a targeted consulting engagement, or a combination of both is the right next step for your organization.
Who This Is For
This consultation is built for development and quality teams at any stage — whether you are mapping out a V&V strategy from scratch, preparing V&V documentation for a 510(k) or De Novo submission, responding to a deficiency or audit observation related to testing coverage, or stress-testing an existing V&V framework before your next regulatory interaction. If your V&V documentation feels fragile, incomplete, or disconnected from your risk management activities, this call will give you a clear picture of what needs to change and why.
How It Works
We will contact you to select a time that works for you. You will receive a brief preparation guide to help focus the conversation on your specific product, development stage, and regulatory context. No formal preparation required beyond that.
What This Is Not
This consultation is not a substitute for a full V&V audit, test execution support, regulatory strategy engagement, or submission support. If your needs extend beyond an advisory conversation, please contact us so that we may find you a better fit.
Designed for organizations that maintain an existing Quality Management System and need targeted, audit-ready reinforcement across software lifecycle, risk management, and design controls, without rebuilding your core system.
This structured add-on integrates directly into your ISO 13485 QMS framework, closing documentation gaps across IEC 62304 and ISO 14971 requirements. Every deliverable is scoped to strengthen traceability, risk alignment, and regulator readiness from day one.
Includes two 45-minute calls — onboarding and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 10 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
SECTION 1: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 2: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 3: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 4: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This add-on is built for SaMD developers, medical device manufacturers, and regulatory teams who need a defensible, submission-ready software documentation system and don't have time to build it from scratch. It's equally suited to companies preparing for a first FDA submission, closing a notified body audit finding, or formalizing a QMS ahead of a Series A or strategic partnership.
What's Not Included
This product does not include cybersecurity documentation, quality manual development, full QMS build-out, regulatory strategy consulting, or submission support. If your needs extend beyond documentation, or standalone cybersecurity assistance please contact us for a better fit. For organizations requiring cybersecurity compliance documentation, see our IEC 62304 + Cybersecurity QMS Add-On.
Designed for organizations that maintain an existing Quality Management System and need targeted, audit-ready reinforcement across software lifecycle, risk management, design controls, and cybersecurity, without rebuilding your core system.
This structured add-on integrates directly into your ISO 13485 QMS framework, closing documentation gaps across IEC 62304, ISO 14971, and FDA cybersecurity guidance requirements. Every deliverable is scoped to strengthen traceability, risk alignment, and regulator readiness from day one.
Includes two 45-minute calls — onboarding and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 10 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
SECTION 1: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 2: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 3: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 4: Cybersecurity Compliance Cybersecurity Risk Management Procedure · Threat Modeling Template (STRIDE) · Software Bill of Materials (SBOM) Template · Security Requirements Specification · Vulnerability Management Procedure · Incident Response Plan · Cybersecurity Testing Protocol Template
Aligned to FDA's 2025 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 5: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This add-on is built for SaMD developers, medical device manufacturers, and regulatory teams who need a defensible, submission-ready software documentation system — and don't have time to build it from scratch. It's equally suited to companies preparing for a first FDA submission, closing a notified body audit finding, or formalizing a QMS ahead of a Series A or strategic partnership.
What's Not Included
This product does not include quality manual development, full QMS build-out, regulatory strategy consulting, or submission support. If your needs extend beyond documentation, contact us for something that may be a better fit.
Designed for medical device teams that need a robust, audit-ready Quality Management System built to ISO 13485 standards — without the overhead of a full software lifecycle integration.
This structured system delivers a complete documentation framework across all core ISO 13485 process domains, with risk management alignment, design controls, and traceability built in. Every deliverable is scoped to support regulatory inspections, notified body audits, and FDA quality system expectations from day one.
Includes two 45-minute calls — onboarding and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 10 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
This system delivers structured documents and templates organized across core ISO 13485 process domains.
SECTION 1: Quality System Architecture Quality Manual · Quality Policy Template · Quality Objectives Framework · Organizational Roles & Responsibilities Matrix · QMS Scope Definition Template
SECTION 2: Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List Template · Controlled Form Template Set
SECTION 3: Design & Development Controls Design & Development Procedure · Design and Development Plan Template · Design Input Template · Design Output Template · Design Review Record Template · Design Verification Plan Template · Design Validation Plan Template · Design Transfer Procedure · Design Change Record Template · Design History File (DHF) Structure Blueprint
SECTION 4: Risk Management (ISO 14971 Aligned) Risk Management Procedure · Risk Management Plan Template · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk-Benefit Analysis Template · Residual Risk Evaluation Template
SECTION 5: Verification & Validation Framework Verification & Validation Master Plan · Test Protocol Template · Test Report Template · Requirements Traceability Matrix Template · Nonconformity Reporting Template
SECTION 6: CAPA & Nonconformance CAPA Procedure · CAPA Form Template · Nonconforming Product Procedure · Root Cause Analysis Template · Corrective Action Plan Template
SECTION 7: Supplier & Purchasing Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List Template · Purchasing Controls Procedure · Supplier Monitoring Record Template
SECTION 8: Management & Audit Management Review Procedure · Management Review Minutes Template · Internal Audit Procedure · Internal Audit Checklist · Internal Audit Report Template
SECTION 9: Training & Competency Training Procedure · Training Record Template · Competency Evaluation Template · Training Matrix Template
SECTION 10: Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback & Post-Market Surveillance Procedure · Advisory Notice Template
SECTION 11: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This system is built for medical device manufacturers, hardware-focused device teams, and quality professionals who need a complete, inspection-ready QMS without the complexity of a full software lifecycle integration. It's the right foundation whether you're establishing quality infrastructure for the first time, preparing for a notified body audit, or bringing your documentation up to standard ahead of an FDA inspection or strategic partnership.
What's Not Included
This system does not include IEC 62304 software lifecycle documentation, cybersecurity documentation, regulatory strategy consulting, or submission support. For organizations developing Software as a Medical Device, our AI-Accelerated Full QMS System (ISO 13485 + IEC 62304) provides the complete integrated solution. If your needs extend beyond documentation, please contact us for something that may be a better fit.
Designed for startups and scaling teams building regulated software systems. A comprehensive, audit-ready Quality Management System purpose-built for digital health and Software as a Medical Device (SaMD) environments.
This integrated system combines ISO 13485 quality management requirements with IEC 62304 software lifecycle controls, risk management alignment, and end-to-end traceability frameworks, delivering everything your team needs to operate, document, and demonstrate compliance without building from scratch.
Includes three 45-minute calls (onboarding, mid-point check-in, and final walkthrough) to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery with 15 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
This integrated system delivers structured documents and templates across quality management, software lifecycle control, and risk-based validation.
SECTION 1: Quality Management System (ISO 13485)
Governance Quality Manual · QMS Scope Statement · Quality Policy · Quality Objectives Template · Organizational Responsibility Matrix
Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List · Document Change Log · Controlled Form Template
Management Responsibility Management Review Procedure · Management Review Agenda Template · Management Review Minutes Template · Management Review Action Log
Internal Audit Internal Audit Procedure · Audit Schedule Template · Audit Checklist (General) · Audit Report Template
CAPA & Nonconformance CAPA Procedure · CAPA Form · Nonconforming Product Procedure · Nonconformance Report Template · Root Cause Analysis Template · Corrective Action Plan Template
Supplier Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List · Supplier Monitoring Log · Purchasing Controls Procedure · Supplier Agreement Template
Training & Competency Training Procedure · Training Record Template · Training Matrix · Competency Evaluation Form
Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback Handling Procedure · Advisory Notice Template · Post-Market Surveillance Plan
SECTION 2: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 3: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 4: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 5: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This system is built for SaMD developers, digital health startups, and medical device teams who need a complete, defensible QMS from the ground up — and need it to hold up under FDA scrutiny, notified body review, or investor due diligence. It's the right starting point whether you're preparing for a first 510(k) submission, pursuing CE marking under EU MDR, or establishing quality infrastructure ahead of a funding round.
What's Not Included
This system does not include cybersecurity documentation, regulatory strategy consulting, or submission support. For organizations developing networked or connected SaMD, our IEC 62304 + Cybersecurity QMS Add-On is available as a companion product. If your needs extend beyond documentation, please contact us for something that may be a better fit.
Designed for organizations building connected or networked Software as a Medical Device who need a complete, submission-ready compliance infrastructure — built to the highest regulatory standard in a single integrated system.
This flagship system combines ISO 13485 quality management, IEC 62304 software lifecycle controls, and FDA-aligned cybersecurity documentation into one cohesive framework. Every section is structured for traceability, risk alignment, and regulator readiness — whether you're targeting FDA premarket submission, EU MDR conformity, or notified body certification.
Includes four 45-minute calls — onboarding, two mid-point check-ins, and final walkthrough — to align all deliverables with your product scope, lifecycle stage, and regulatory objectives.
Delivery within 20 Business Days from onboarding call.
Deliverable Format All documents delivered as fully editable Word files in a structured folder architecture with numbered document hierarchy and implementation guidance notes embedded throughout.
This integrated system delivers structured documents and templates across quality management, software lifecycle control, cybersecurity compliance, and risk-based validation.
SECTION 1: Quality Management System (ISO 13485)
Governance Quality Manual · QMS Scope Statement · Quality Policy · Quality Objectives Template · Organizational Responsibility Matrix
Document & Record Control Document Control Procedure · Record Control Procedure · Change Control Procedure · Master Document List · Document Change Log · Controlled Form Template
Management Responsibility Management Review Procedure · Management Review Agenda Template · Management Review Minutes Template · Management Review Action Log
Internal Audit Internal Audit Procedure · Audit Schedule Template · Audit Checklist (General) · Audit Report Template
CAPA & Nonconformance CAPA Procedure · CAPA Form · Nonconforming Product Procedure · Nonconformance Report Template · Root Cause Analysis Template · Corrective Action Plan Template
Supplier Controls Supplier Evaluation Procedure · Supplier Qualification Form · Approved Supplier List · Supplier Monitoring Log · Purchasing Controls Procedure · Supplier Agreement Template
Training & Competency Training Procedure · Training Record Template · Training Matrix · Competency Evaluation Form
Post-Market & Feedback Complaint Handling Procedure · Complaint Record Template · Feedback Handling Procedure · Advisory Notice Template · Post-Market Surveillance Plan
SECTION 2: IEC 62304 Software Lifecycle
Lifecycle Planning Software Development Plan · Software Safety Classification Framework · Software Configuration Management Plan · Software Maintenance Plan · Software Problem Resolution Procedure · Software Release Plan
Requirements & Architecture Software Requirements Specification · System Requirements Specification · Architecture Description Template · Detailed Design Template · Interface Specification Template · Requirements Change Log · Requirements Review Record · Software Requirements Trace Log
Risk Management (ISO 14971 Aligned) Risk Management Procedure · Software Risk Management Plan · Hazard Analysis Template · Risk Register Template · Risk Control Matrix · Risk Evaluation Form · Residual Risk Evaluation Template · Risk Review Meeting Record
Verification & Validation Verification & Validation Master Plan · Unit Test Protocol Template · Unit Test Report Template · Integration Test Protocol · Integration Test Report · System Test Protocol · System Test Report · User Acceptance Test Plan · UAT Report Template · Verification Summary Report
Configuration & Change Management Configuration Identification Log · Configuration Change Request Form · Software Baseline Record · Version Control Log · Build Release Record · Change Impact Assessment Template
SECTION 3: Integrated Design Controls Design & Development Procedure · Design and Development Plan · Design Input Template · Design Output Template · Design Review Record · Design Verification Plan · Design Validation Plan · Design Transfer Record
SECTION 4: Traceability & DHF End-to-End Traceability Matrix · Risk-to-Control Mapping Matrix · Requirements-to-Test Coverage Matrix · DHF Index Template · Technical File Index Template · Submission Readiness Checklist
SECTION 5: Cybersecurity Compliance Cybersecurity Risk Management Procedure · Threat Modeling Template (STRIDE) · Software Bill of Materials (SBOM) Template · Security Requirements Specification · Vulnerability Management Procedure · Incident Response Plan · Cybersecurity Testing Protocol Template
Aligned to FDA's 2023 Cybersecurity in Medical Devices guidance and EU MDR/IVDR expectations for networked and software-based devices.
SECTION 6: Implementation Acceleration Tools AI Documentation Prompt Library · AI-Assisted Gap Analysis Prompts · Document Review Checklist Library · 30-60-90 Day Implementation Roadmap
Purpose-built tools to accelerate document population, close gaps faster, and keep your team aligned through each phase of implementation.
Who This Is For
This system is built for SaMD developers and digital health teams building connected, networked, or cloud-based medical devices who need the most complete compliance infrastructure available in a single purchase. It's the right choice for organizations preparing for FDA premarket submission under current cybersecurity guidance, pursuing CE marking under EU MDR, or establishing enterprise-grade quality infrastructure ahead of a Series A or strategic partnership.
What's Not Included
This system does not include regulatory strategy consulting, submission support, or custom cybersecurity architecture assessment. If your needs extend beyond documentation, [link to your consulting services page] may be a better fit.
Designed for organizations that have a quality management foundation in place and need structured expert guidance to implement it with discipline, defensibility, and regulatory intent — not just good intentions.
This is not a document delivery service. This is a 30-day advisory engagement focused on architecture, process integration, and implementation rigor. You will work directly with an experienced medical device regulatory consultant across four structured weekly sessions, with ongoing support between sessions, to build a QMS that is genuinely audit-ready — not just technically complete.
Who This Is For
This engagement is built for quality and regulatory teams who are serious about implementation. It is equally suited to organizations establishing QMS infrastructure for the first time, teams remediating gaps identified in an FDA inspection or notified body audit, and companies preparing for a 510(k) submission, CE marking, or investor due diligence where QMS defensibility is under scrutiny.
Organizations that have established a foundational QMS document system will get the most out of this engagement. If you do not yet have a structured documentation foundation in place, our AI-Accelerated QMS Systems [link to QMS products] are the recommended starting point before beginning this advisory.
Engagement Structure
Duration: 30 calendar days from onboarding call.
Onboarding Session: 60-minute kickoff and system assessment to establish baseline, align objectives, and map the engagement to your specific regulatory context and implementation priorities.
Weekly Advisory Sessions: Four structured sessions of 60–90 minutes each, organized around a progressive implementation framework designed to build momentum and accountability across the full 30 days.
Email Support: Ongoing clarification and guidance between sessions to keep implementation moving without waiting for the next call.
Written Deliverables: Structured milestone summary and prioritized next-step implementation plan delivered at engagement close.
How It Works
Week 1 — System Assessment & Architecture Review We begin with a thorough review of your current QMS structure, document hierarchy, and risk integration posture. By the end of week one you will have a clear picture of your baseline, your most significant gaps, and the implementation priorities that will drive the remaining three weeks.
Week 2 — Process Integration & Gap Prioritization We align your procedures with ISO 13485 requirements and IEC 62304 software lifecycle controls where applicable, define your corrective priorities, and begin integrating your processes into a coherent, traceable system rather than a collection of standalone documents.
Week 3 — Implementation Calibration We refine your change control, design controls, traceability framework, and documentation flow — making sure the system works in practice, not just on paper. This is where most QMS implementations break down, and where structured advisory guidance has the highest impact.
Week 4 — Readiness & Control Review We conduct a final review of your QMS structure, governance alignment, and regulator-facing defensibility. You will leave week four with a system you can stand behind in front of an FDA investigator, a notified body auditor, or an investor's due diligence team.
What You Walk Away With
At the close of the engagement you will have a QMS that is architecturally sound, process-integrated, and defensible under regulatory scrutiny — along with a written milestone summary documenting what was built, what was refined, and the prioritized next steps for ongoing maintenance and continuous improvement.
More importantly, your team will understand the system — how it works, why it is structured the way it is, and how to maintain it going forward. That operational confidence is what separates a QMS that survives an audit from one that falls apart under questioning.
What This Is Not
This engagement is not a full outsourced QMS development service, submission support, or regulatory strategy consulting. It is a structured advisory designed to guide your team through implementation with expert oversight. The work is collaborative — you build it, we make sure you build it right.
If your needs extend beyond guided implementation, please contact us for a service that may be a better fit.